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In the usa, the manufacture and sale of OTC substances is regulated by the Fda (FDA). Manufacture has to be either pursuant for an FDA monograph, which specifies types of OTC drugs, active ingredients and labeling requirements, or pursuant with a New Drug Application (NDA), for products which do not fit inside a specific monograph.Medications are likely to be split into two groups - non-prescription (OTC) medications, which are available in pharmacies and supermarkets without special restrictions, and prescription only medicines (POM), which has to be prescribed by a physician. Most of the OTC medications are generally considered safe enough as they cannot harm people if taken as instructed.
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